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Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00526487
First Posted: September 10, 2007
Last Update Posted: March 1, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Cook Group Incorporated
MED Institute, Incorporated
William Cook Australia
Information provided by (Responsible Party):
Cook Group Incorporated ( William Cook Europe )
September 5, 2007
September 10, 2007
March 1, 2017
December 2007
July 2011   (Final data collection date for primary outcome measure)
The primary endpoint is survival at 30 days [ Time Frame: 30 days ]
The primary endpoint is survival at 30 days
Complete list of historical versions of study NCT00526487 on ClinicalTrials.gov Archive Site
Measure: Clinical utility, incidence and rate of adverse events, mortality, factors related to morbidity [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Clinical Study to Assess Safety and Effectiveness of the Zenith® Dissection Endovascular System in Patients With Aortic Dissection
Evaluation of the Safety and Effectiveness Performance of the Zenith® Dissection Endovascular System in the Treatment of Patients With Aortic Dissection Involving the Descending Thoracic Aorta
The purpose of this study is to evaluate the safety and effectiveness performance of the Zenith® Dissection Endovascular System in the treatment of aortic dissections involving the descending thoracic aorta.
The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Aortic Dissection Involving the Descending Thoracic Aorta
  • Device: Zenith® Dissection Endovascular System
    The Zenith® Thoracic Dissection Study is a clinical trial to study the safety and effectiveness of the Zenith® Dissection Endovascular System in the treatment of dissections (length-wise tear) of the descending thoracic aorta. The Zenith® Dissection Endovascular System is comprised of the Zenith TX2® TAA Endovascular Graft and the Zenith® Dissection Endovascular Stent. Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the graft and the dissection stent into place in the aorta.
  • Device: Endovascular Repair
    Endovascular Repair
1
Endovascular Repair
Interventions:
  • Device: Zenith® Dissection Endovascular System
  • Device: Endovascular Repair
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
September 2016
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Branch vessel obstruction/compromise
  • Peri-aortic effusion/hematoma
  • Resistant hypertension
  • Persistent pain/symptoms
  • Transaortic growth greater than or equal to 5 mm within 3 months (or transaortic diameter greater than or equal to 40 mm)

Exclusion Criteria:

  • Age less than 18 years
  • Frank rupture
  • Diagnosed or suspected congenital degenerative connective tissue disease
  • Systemic infection
  • Untreatable reaction to contrast
  • Surgical/endovascular AAA repair within 30 days
  • Previous placement of thoracic endovascular graft
  • Prior repair of descending thoracic aorta
  • Interventional/open procedures within 30 days
  • Onset of symptoms > 3 months
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Czech Republic,   France,   Germany,   Italy
 
 
NCT00526487
07-004
370010, TXD
No
Not Provided
Not Provided
Cook Group Incorporated ( William Cook Europe )
William Cook Europe
  • Cook Group Incorporated
  • MED Institute, Incorporated
  • William Cook Australia
Principal Investigator: Joseph Lombardi, MD Thomas Jefferson University
Cook Group Incorporated
February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP